Application of Digital Twins' Technology in Patients Who Had a Stroke, with Moyamoya Disease and with Cerebral Amyloid Angiopathy (CAA) During the Secondary Prevention Phase: a Proof of Concept Using a Randomized Control Trial (Clinical Study 6, STRATIF-AI Project)

Launched by FONDAZIONE I.R.C.C.S. ISTITUTO NEUROLOGICO CARLO BESTA · Dec 2, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new technology called the STRATIF-AI platform, which uses a concept known as "digital twins" to help patients who have experienced a stroke, Moyamoya disease, or Cerebral Amyloid Angiopathy (CAA). The main goal is to see how patients feel about using this app alongside their regular treatment to prevent further health issues. Participants will be divided into two groups: one group will use the STRATIF-AI app daily while following their usual treatment, and the other group will only receive standard treatment without the app. Researchers will gather feedback on how easy the app is to use and how helpful it is over six months.

To be eligible for this trial, participants need to be at least 18 years old and have specific diagnoses related to stroke, Moyamoya disease, or CAA. They should also be able to complete some cognitive tests and sign consent forms. During the trial, all participants will undergo assessments at the beginning and after six months to track their progress. Those in the group using the app may also have the option to buy wearable devices that connect to it for better health management. This study is not yet recruiting participants, but it aims to better understand how technology can support patients in managing their health.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • People aged ≥ 18
• • Clinical and neuroradiological diagnosis of stroke (TAC or MR); diagnosis of CAA based on Boston 2.0 criteria; diagnosis of Moyamoya disease based on diagnostic criteria 2021.
• • MOCA total score ≥ 23
• • modified Rankin Scale (mRS) ≤ 2
• • First-time patients at the Besta Institute
• • Ability to sign informed consent
• • Possibility of performing a brain MRI
• Exclusion Criteria:
• • Patients with transient neurological deficits that resolve within an hour and normal brain imaging
• • Patient under legal protection or deprived of liberty by judicial or administrative decision
• • Patient whose follow-up will be impossible
• • Contraindication to magnetic resonance imaging and/or Digital subtraction angiography (DSA)
• • Pregnant patients
• • Known or suspected drug or alcohol abuse